Access disconnect detection system

ABSTRACT

An access site disconnection system and method are disclosed. Radio frequency transmitters and receivers are placed near an access site. When a patient receives dialysis treatment, wetness may arise from blood if the access needle becomes disconnected from the access site. Radio-frequency transmitters are mounted on or near gauze or other absorbent material placed adjacent the access site, as are radio-frequency receivers. After the sensors are placed, the dialysis machine and radio-frequency control circuit may be initialized or baselined, and dialysis treatment, such as hemodialysis, begun. If blood leaks from the access site, such as if the access needle is dislodged, the blood attenuates the radio frequency transmissions, which are detected by the receivers. A signal is sent to a controller or to an output device to raise an alert or sound an alarm.

PRIORITY

This application claims priority to and the benefit as a continuationapplication of U.S. patent application entitled “Access DisconnectDetection System”, Ser. No. 11/859,589, filed Sep. 21, 2007, the entirecontents of which are incorporated herein by reference and relied upon.

The field of the invention is medical treatments generally and patientvascular access systems. The present invention relates to embodiments ofa method and a system for detecting disconnection of an access needle orcatheter while receiving medical treatment.

The maxim of “first, do no harm,” may be a good summary of theHippocratic oath required of doctors and practiced by medicalprofessionals. Nowhere is this principle required more than in modernmedicine. With patients living longer, there are more extendedtreatments and more frail patients than ever. Such patients are indanger from a number of complications that can arise from continuingtherapeutic procedures, and even from diagnostic procedures, that arenecessary for their continued care. Treatments involving extra-corporealblood treatment are clear examples.

The most obvious danger is infection, but the harm caused by infectioncan be overcome by not re-using even supposedly-sterile devices, bydiligent attention by the patient himself or herself, and by the carefulattention of care givers attending the patient. Other problems alsoarise, but, like infections, have been difficult to eradicate. One ofthe problems arises in blood treatment procedures in which the patient'sblood is physically removed for treatment and then returned, all in thesame procedure. Removal and return of blood is practiced inhemodialysis, for those persons whose kidneys do not function well.Other procedures, such as apheresis, involve removing blood from apatient or a donor, subjecting the blood to a centrifugal treatment toseparate blood platelets or plasma from red blood cells, and thenreturning the red blood cells to the patient or donor, as described inU.S. Pat. Nos. 5,427,695 and 6,071,421.

The extracorporeal medical treatments described above require that theblood be removed for treatment and then returned. This requires accessto the patient's vascular system, from which blood is removed and towhich blood is then returned. If a “batch” treatment is used, that is, aquantity of blood is withdrawn, treated and returned, only a singleneedle is used. Each batch treatment is typically short, and thetreatment is attended by a medical professional at a clinic or hospital.Other treatments are continuous, such as the platelet separationdiscussed above, or dialysis treatment, and may require a duration ofseveral hours or even overnight. There is also a “batch continuous”method in which a single needle is used. There are distinct draw andreturn phases of a batch continuous process. During the draw phase,blood is processed and additional blood is sent to a holding containerto the processed during the return phase. During the return phase, bloodis processed from the holding container and returned to thepatient/donor through the single needle.

Continuous treatments require two needles, or access points, one forwithdrawal of blood and one for return. The withdrawal site is normallyan artery although a vein could also be used, and a needle and a pumpare used to provide the blood to the therapeutic machine. It isrelatively simple to detect a problem with withdrawal, for instance, ifthe withdrawal needle is dislodged. Bubbles form in the withdrawal lineand conventional air sensors detect the bubbles. Detecting a problem inthe return of the blood to the patient is more difficult. The returnline typically includes a needle with venous access. If the return lineis dislodged, the blood is not returned to the patient, but may continueto be pumped and may accumulate near the patient, but not returned tothe patient's vascular system. Depending on the pumping rate of theblood and the time for treatment, this could have life-threateningeffects on the patient within a very short period time.

Accordingly, a number of apparatuses have been devised for detectingneedle dislodgement, especially venous dislodgement. An example is U.S.Pat. Appl. Publ. 2006/0130591. In a device according to thisapplication, a venous needle is equipped with a photosensor and iscovered with an opaque patch. This device would not send a signal or analarm if the needle begins leaking or is only slightly dislodged. Thephotosensor could also fail to detect light because the needle has notbeen dislodged sufficiently to expose the photosensor to light.

Another example is U.S. Pat. No. 7,052,480, in which an induction coilis attached to a venous blood line and a second coil is attached to thearterial blood line. An electric current is generated and injected intothe blood circuit, passing from one coil through the blood to the secondcoil. Signal processing circuitry is able to detect any variation in theresulting current in the second coil, and can interpret any significantchange in the current, impedance, voltage, resistance, and so forth, asan indication of a leak or of dislodgement. This technique iscomplicated and difficult to set up for consistent, reliable operation,in consideration of natural variances over long periods of time, andalso considering differences between patients.

Another example is provided in U.S. Pat. 7,060,047, in which an electricsignal is also injected into the patient and is used to form acapacitor. A ring electrode is placed around the tubing of the venousbranch, between the drip chamber of a hemodialysis machine and theaccess needle returning blood to the patient. The blood of the patientforms the other plate of the capacitor. An electronic circuit is used tomonitor the voltage across the plates of the capacitor. When the venousaccess needle is dislodged, a large change in the voltage results, andis detected by the electronic circuit. This technique has thedisadvantage that a voltage change may not result until the blood hasbeen exhausted and no longer fills the tubing in the return line.

Numerous other techniques have been devised, many of them depending on aflow of blood causing conductivity between two electrodes or two wires.One problem with these methods is that it is not easy to distinguishbetween small amounts of blood and the natural perspiration of a person,which can cause false alarms. What is needed is a better way of quicklydetecting dislodgement of a venous or other needle or catheter from apatient, so that inadvertent loss of blood and harm to the patient isavoided.

SUMMARY

One embodiment is an access disconnect detector. The access disconnectdetector includes at least one radio-frequency transmitter, at least oneradio-frequency receiver, and a mount suitable for mounting the at leastone radio-frequency transmitter and at least one radio-frequencyreceiver, wherein the mount and the at least one transmitter andreceiver are configured for positioning adjacent an access site fordetecting a presence of blood of a patient, and wherein the access siteis positioned between the at least one radio-frequency transmitter andthe at least one radio-frequency receiver so that the at least oneradio-frequency receiver receives one level of signals from the at leastone radio-frequency transmitter when the access site is dry and receivesa lower level of signals when the access site is wetted.

Another embodiment is an access disconnect detector. The accessdisconnect detector includes a flexible mount suitable for attaching toa patient, an array including at least one radio-frequency transmitterand at least one radio-frequency receiver mounted on a first side of themount, and a pad of absorbent material on the array, wherein the mountand the at least one transmitter and at least one receiver areconfigured for positioning adjacent a dialysis access site for detectinga presence of blood of the patient, and wherein the at least onetransmitter and at least one receiver are configured so that the atleast one receiver receives one level of signals from the at least onetransmitter when the at least one transmitter and the at least onereceiver are dry and receives a lower level of signals when one of theat least one transmitter and at the least one receiver is wetted withblood.

Another embodiment is an access disconnect detector. The accessdisconnect detector includes at least one radio-frequency transmitterfor placement on a person, at least one radio-frequency receiver forplacement on a person, and a flexible layer adjacent the at least onetransmitter and the at least one receiver, wherein the transmitter andthe receiver are mounted on a single side of the flexible layer forrapid detection of blood from the person.

Another embodiment is a method for detecting an access sitedisconnection. The method includes steps of placing at least oneradio-frequency transmitter and at least one radio-frequency receiveradjacent the access site, sending a transmission from the at least oneradio-frequency transmitter to the least one radio-frequency receiver,receiving the transmission at a baseline level by the at least oneradio-frequency receiver, periodically repeating the steps of sendingand receiving, and sending a signal if the transmission sent by the atleast one radio-frequency transmitter is not received at the baselinelevel by the at least one of the radio-frequency receiver.

Additional features and advantages are described herein, and will beapparent from, the following Detailed Description and the figures.

BRIEF DESCRIPTION OF THE FIGURES

FIG. 1 depicts a plan view of a first embodiment of an access disconnectdetector;

FIG. 2 depicts additional elements of the embodiment of FIG. 1;

FIG. 3 depicts a flow chart showing a method of using an accessdisconnect detector;

FIGS. 4-9 depict circuits and antennae useful in embodiments of anaccess disconnect detector;

FIG. 10 depicts another embodiment of a radio frequency accessdisconnect detector; and

FIG. 11 depicts the effect of frequency on the loss factors of blood andwater.

DETAILED DESCRIPTION

There are many embodiments of the invention, of which only a few aredescribed in the figures and detailed description below. A firstembodiment of an access disconnect detector is depicted in FIG. 1.Access disconnect detector 10 is mounted on arm A of a patient, near avenous access site V with a venous access needle V_(n). In thisembodiment, the detector includes a first plurality 11 ofradio-frequency transmitters and a first plurality 13 of radio-frequencyreceivers. In this application, the term transmitter refers to either anactive or passive transmitting antenna. A passive antenna may be used toreduce the size, complexity, and cost of the detector. The term receiverrefers to either an active or passive receiving antenna. A passiveantenna may be used to reduce the size, complexity, and cost of thedetector. The frequencies of interest are any frequencies generallyreferred to as radio frequencies, from as low as about 50 kHz to 10 GHz.Other ranges of interest include 2 GHz to 6 GHz, which includes thecommonly-used 2.45 GHz and 5.8 GHz. 5.8 GHz in particular uses verysmall antenna.

The transmitters are mounted on one side of the access site, with thereceivers mounted on the opposite side. The pluralities 11, 13 oftransmitters and receivers are mounted on one side of a mounting pad 15,with the transmitters and receivers mounted adjacent the patient, ratherthan on the side of the mounting pad facing away from the patient. Theremay also be a layer of absorbent material 17 on the other side of thetransmitters and receivers, the absorbent material intended forplacement on the patient and on the access site using strips of adhesive18. The detector 10 is connected by cable 19, including coaxial cable 19a, splitter 19 b, combiner 19 c, and cable 19 d, to a controller 20,which may also include a power source for the detector.

The mounting pad is flexible so that its shape is adaptable to the exactshape of the patient's arm or leg, or other access site. Silicone padsmay be used, as may urethane pads. Other elastomers may be used, as mayother suitable plastic materials. The absorbent material makes thedetector more acceptable to the patient by presenting a soft,comfortable surface to the patient. The absorbent material also wicksblood and better enables the detector to retain even small amounts ofblood that leak from the access site. The absorbent material wicks bloodand moves at least some of the blood by surface tension to the areabetween the transmitters and receivers.

It is well known that liquids tend to scatter radio frequency radiation.Thus, when blood flows into or is wicked into areas between thetransmitters and receivers, the radio frequency radiation is scatteredand is not received at the receivers, at least not at the signalintensity that was received before the leakage or disconnect from theaccess site. A large amount of sweat absorbed into the bandage couldcause a small change in signal intensity. However, blood has a higherloss factor (the rate at which radio frequency radiation is absorbed)than water, which is the main component of sweat. See FIG. 11. The saltin sweat would also cause a small amount of RF absorption, but theconcentration of salt in sweat is much lower than that of blood.Therefore the reduction in signal (from baseline) will be significantlyhigher with a blood accumulation than if the patient were to sweat. Thiscan be used when setting up and calibrating the system for use withpatients.

It will be clear to those having skill in the art that a plurality ofradio frequency transmitters and receivers will do an excellent job ofdetecting blood leakage from an access site from which the access needlehas become disconnected. It is not necessary to have a plurality oftransmitters and receivers, because a single transmitter and a singlereceiver, located on opposite sides of the access site are also fullycapable of detecting blood. More than one transmitter and more than onereceiver may also be used, at the price of a small bit of additionalweight and discomfort to the patient. The mounting pad and the detectoras a whole may become heavier and larger as more transmitters andreceivers are added. While each transmitter and receiver may be verysmall, some no larger than 1 square cm, the cumulative area they occupy,along with connections and other components, grows with the number oftransmitters and receivers added.

The radio transmitters and receivers may be mounted individually or maybe mounted on a single circuit as shown in FIGS. 1-2. The transmittercircuit 11 includes a polyimide flex circuit layer 24. An alternatematerial also well-suited for radio frequency application is RogersR/Flex. Polyimide may be plated with copper or other suitable conductivematerial. Ceramic material such as that of Rogers 6010, or other circuitboard material, even FR-4, epoxy-fiberglass, or other materials, mayalso be plated and etched to make suitable antennae. On the top side, atop layer of copper is etched to prepare the four tapered patch antennae26 shown. The bottom layer of the circuit board also includes a copperlayer 25, that has been etched to form a ground plane under each of theantennae.

The receiver circuits are constructed in a virtually identical manner,with a circuit board 27, receiver antennae 29, and a ground plane 28 foreach antenna. Using a dual-plane circuit board with antennae as shown,each antenna will transmit radio frequency waves off the forward edge ofthe antenna, that is, each will be edge-firing. This will direct theradio frequency beams directly as the transmitter antennae are aimed,that is, directly across the access site to the row of receivercircuits. These are examples of microstrip antennae. A microstripantenna generally includes a dielectric substrate with a ground plane onone side and a conductor on the other side. The conductor and the groundplane are typically made of copper. The conductor is also surrounded bya second dielectric, which may be air or may be another dielectric.

Since these are radio frequency waves, it is necessary to useradio-frequency equipment, e.g., coaxial cable, to transmit the wavesfrom an RF generator to the transmitting antennae 26 and from thereceiving antennae 29. Coaxial cables 19 a, 19 b each have a centerconductor and shielding, typically a copper or steel mesh type material.The center conductor is connected to a splitter 19 b, which connects tothe center conductor and then divides into four additional connectors,one for each antenna 26. On the receive side, each antenna connects to acombiner 19 c, which may be the same as the combiner 19 b. Combiner 19 cconnects to the center conductor of coaxial cable 19 d. The shielding ofcable 19 d connects to the ground planes 28 of the receive antennae.RG-178, for example, is a lightweight, flexible, and small diameter (2-3mm) coaxial cable. SMA (sub-miniature A) type connectors can also beused, and slip-on type SMA connectors can be used for quickconnect/disconnect connections.

The radio frequency waves are generated by an RF generator 23, as partof a detector circuit or as part of the therapy machine. The detectorcircuit also includes an amplifier 21 to receive and amplify thecaptured signal and signal processing circuitry 22 to process thereceived data and to determine whether the signal is within a desiredrange, or whether blood has been detected.

The amount of material and its location on the access site should becontrolled, e.g., by adhering the absorbent material in place by sewingto the mounting pad 15, or by carefully using an adhesive, orhook-and-loop fasteners, such as those available under the trademarkVelcro®, to adhere the absorbent material to the pad or to the circuitboard or flex circuit for the transmitters and receivers. Adhesives maybe used, but they may contain small residual amounts of water that mayscatter the radio-frequency radiation. A sleeve or pad may also bewrapped around the patient's arm or leg and secured with metallic orplastic fasteners, or with hook-and-loop fasteners.

In one way of using this embodiment, a health care professional or acare giver, or even the patient himself or herself, may administerhemodialysis or other therapy. An arterial access needle (not shown) andthe venous access needle are connected to a therapy machine and insertedinto the patient. The care giver or patient then places the detector padover the access site and secures it in place using adhesive strips 18that are placed on the outer perimeter of the detector 10 or the pad 15,and are not placed between the transmitters and the receivers. Thetherapy machine is turned on and the controller 20 is activated.Controller 20 may be a stand-alone controller for the detector, or maybe part of the therapy machine, such as a hemodialysis machine orapheresis or blood separation machine.

The transmitters and receivers are given an initial reading to determinewhether they are working properly. After adjusting for particularon-site parameters, the detector is optimized for acceptabletransmit/receiver power and reception levels. This may be considered abase line or initialization level. Once therapy has begun, thetransmitters may be programmed to periodically send a radio-frequencysignal to the receivers, such as once or twice per second, or even moreoften, or less often. In one embodiment, a signal is sent from at a ratefrom about 0.5 Hz (about once every two seconds) to about 2 Hz (or abouttwice per second). Other rates may be used. The receivers receive thesignal at a commensurate power level. If a signal is not sent, there maybe something amiss with the transmitter or the control circuitry. If asignal is not received, there may be something amiss with the receiveror the control circuitry, or it may be that blood has been detected. Ifblood enters the absorbent material, or the area between thetransmitters and receivers, the radio frequency radiation is scatteredand the signal detected by the receiver will be diminished. Thediminishment, or the extent of the diminishment, may be determined byexperiment and used to calibrate or “train” the particular detector orhemodialysis setup being used.

Several steps of a method of using the radio-frequency blood detectorare depicted in the flowchart of FIG. 3. As mentioned, the detector thatis furnished 31 is a pad with one or more radio frequency transmittersand receivers. The detector is mounted 32 near the patient access site.The controller is turned on and initialized, and a first radiotransmission is made through the transmitters and receivers. A baselinelevel for transmission power and receipt is determined 33 and theequipment is ready. Therapy is then begun, and as mentioned, periodictransmissions are made 34 through the transmitters and receivers toinsure that blood is not present. A short burst of signals may be sentat intervals of about one-tenth of a second to about every second, i.e.,1-10 Hz, or at other intervals, from about 0.5 to about 2 Hz. If thecontroller notes that the receiver is not receiving power at thebaseline level, or that the transmitter is not sending a signal at thebaseline level, a signal may be sent 35 to the therapy machine or to acaregiver. As a result, therapy may be ceased 36, or an alarm or analert sounded, or both.

Coaxial cable is needed to contain the RF signal and maintain itsintegrity. Circle, square, or other polygon patch antennas fire(transmit) the radio wave in a direction that is perpendicular to thebroad face of the sensor. Other antennae suitable for face-firing radioantennae include the spiral planar antenna depicted in FIGS. 4-6, aspiral antenna 41, a hexagon 42 and an octagon 43. These antenna areuseful in this application for aiming the radio transmissions at anangle to the access site rather than straight across the access site.

Another type of firing mode is edge-firing. Single and double dipoleantennae are depicted, respectively, in FIGS. 7 and 8. These devicesinclude single dipole antennae 44 and dual dipole 45. Another example ofan antenna that works well for edge-firing applications is the Yagi-typeantenna 46 depicted in FIG. 9. They may be used to send or receivesignals. Each of these antennae may be used to transmit as well as toreceive. Each is an example of a microstrip antenna and each may be madeby the same etching process used for etching printed circuit boards.They may also be made by printing processes, e.g., using ink-jetprinting with conductive inks.

Another example of an access disconnection detector usingradio-frequency transmitters and receivers is depicted in FIG. 10.Detector 90 is connected to a controller or control circuitry 100 viacoaxial cables 91. The detector includes a flex circuit 92, with oneradio frequency transmitter 93, intended for placement on one side ofthe venous access site V and access needle V_(n), and a radio frequencyreceiver 94, intended for placement on an opposite side of the accesssite. The transmitter and receiver each have a spiral antenna as shownand a ground plane 95, 96.

Cable 91 is lightweight and extends to controller 100 for carrying theRF signals. Controller 100 may be a stand-alone controller for theaccess disconnect detector, or it may be a part of a therapy machine,such as a hemodialysis or apheresis machine. Controller 100 includescircuitry and logic necessary to generate radio frequency signals to thetransmitter and to receive, process and interpret signals received fromthe detector and the receiver. The controller includes a microprocessorand at least sufficient logic, in the form of software on a computerreadable medium, to interpret the RF transmissions and to send a signalif blood is detected by the blood detector. The signal may be to ceasetherapy and to alert the patient or the caregiver via local screen 101,local speaker 103, through antenna 105, or via a wired connection,. Thecontroller also includes inputs, such as a keyboard 104 and a disc drive105 for input/output. There may also be a wired input via standard wirecable or fiber optic, such as for a hospital information system or aclinic computer system.

The logic includes guidelines for the amount of signal reduction that isrequired before an alert or an alarm is sounded. For example, thedetector and the controller may be programmed to require threeconsecutive signals in which the RF transmission received is only halfof the expected level before sending a signal or an alert. Some othersignal loss level may be used, and a greater or lesser number ofconsecutive or non-consecutive signals may be used instead. The idea isto use more than one transmitter-receiver pair to avoid dependence on asingle signal for blood detection, and to use more than a single signalto also avoid false alarms, which may unduly delay needed therapy, whilealso safeguarding the patient from blood loss.

It should be understood that various changes and modifications to thepresently preferred embodiments described herein will be apparent tothose skilled in the art. Such changes and modifications can be madewithout departing from the spirit and scope of the present subjectmatter and without diminishing its intended advantages. It is thereforeintended that such changes and modifications be covered by the appendedclaims.

What is claimed is:
 1. An access site disconnection detection methodcomprising: sending a radio-frequency transmission; receiving theradio-frequency transmission when the access site is dry to establish abaseline level; repeating the sending of the radio-frequencytransmission at least once; receiving the at least one repeatedradio-frequency transmission at a level that has fallen below thebaseline level if the access site is wet; and sending a blood leakagedetection signal in response to the at least one repeatedradio-frequency transmission having fallen below the baseline level. 2.The access site disconnection detection method of claim 1, whichincludes sending the radio frequency transmissions at a frequency ofabout .5 Hz to about 2 Hz.
 3. The access site disconnection detectionmethod of claim 1, which includes sending the radio frequencytransmissions at a frequency of about 1 Hz to about 10 Hz.
 4. The accesssite disconnection detection method of claim 1, which includesgenerating the sent radio-frequency transmissions via a controller of ablood treatment machine.
 5. The access disconnection detection method ofclaim 1, which includes sending the signal in response to the at leastone repeated radio-frequency transmission having fallen below thebaseline level as sensed by any one of a plurality of radio-frequencyreceivers.
 6. The access site disconnection detection method of claim 1,which includes issuing an alarm and/or stopping a pump in response tothe sending of the blood leakage detection signal.
 7. The access sitedisconnection detection method of claim 1, which includes sending theblood leakage detection signal if the at least one repeatedradio-frequency transmission falls below half of the baseline level. 8.The access site disconnection detection method of claim 1, whichincludes mounting at least one radio-frequency transmitter and at leastone radio frequency receiver on at least one electrical circuit.
 9. Theaccess site disconnection detection method of claim 8, wherein the atleast one electrical circuit is flexible.
 10. The access sitedisconnection detection method of claim 1, which includes absorbingblood leaking from an access site disconnection with an absorbent layer.11. An access site disconnection detection method comprising: sending aradio-frequency transmission; receiving the radio-frequency transmissionwhen the access site is dry to establish a baseline level; repeating thesending of the radio frequency transmission a plurality of times;receiving the repeated radio-frequency transmission a plurality of timesat a level that has fallen below the baseline level if the access siteis wet; and sending a blood leakage detection signal in response to therepeated radio-frequency transmission having fallen below the baselinelevel a plurality of times.
 12. The access site disconnection detectionmethod of claim 11, which includes sending the radio frequencytransmissions at a frequency of about .5 Hz to about 2 Hz.
 13. Theaccess site disconnection detection method of claim 11, which includessending the radio-frequency transmissions from a first circuit board toa second circuit board.
 14. The access site disconnection detectionmethod of claim 11, which includes sending the radio-frequencytransmissions via antennae of at least one radio-frequency transmitterand receiving the radio-frequency transmissions via antennae of at leastone radio-frequency receiver.
 15. The access site disconnectiondetection method of claim 14, wherein the antennae is selected from thegroup consisting of (i) spiral antennae, (ii) single dipole antennae,(ii) double dipole antennae, or (iv) a Yagi-type antennae.
 16. Theaccess site disconnection detection method of claim 11, which includessending the radio-frequency transmissions at an angle relative to theaccess site.
 17. The access site disconnecting detection method of claim11, which includes receiving the repeated radio-frequency transmission aplurality of times at the baseline level when no blood leakage hasoccurred at the access site.
 18. An access site disconnection detectionmethod comprising: setting a baseline level for a radio-frequencytransmission received by at least one radio-frequency receiver when theaccess site is dry; sending a radio-frequency transmission from at leastone radio-frequency transmitter; receiving the radio-frequencytransmission by the at least one radio-frequency receiver at a lowerlevel than the baseline level if the access site is wet; and sending ablood leakage detection signal in response to the radio-frequencytransmission being received at the lower level.
 19. The access sitedisconnection detection method of claim 18, which includes setting thebaseline level prior to a blood treatment therapy.
 20. The access sitedisconnection detection method of claim 18, which includes sending theblood leakage detection signal in response to the radio-frequencytransmission being received at the lower level a plurality ofconsecutive times.